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Meeting the needs of children with malaria

Meeting the needs of children with malaria. Hans Rietveld, Director, Global Access and Marketing, Malaria Initiative Novartis Pharma AG London, 23 March 2009. Agenda. The Coartem legacy Rolling out Coartem Dispersible.

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Meeting the needs of children with malaria

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  1. Meeting the needs of children with malaria Hans Rietveld, Director, Global Access and Marketing, Malaria Initiative Novartis Pharma AG London, 23 March 2009

  2. Agenda • The Coartem legacy • Rolling out Coartem Dispersible

  3. Strategy against malaria in endemic countriesHolistic approach combining prevention and cure Malaria can be prevented and controlled by three main strategies: Insecticide Spraying • Control of the mosquitoes by spraying and drainage of areas where they live • Indoor residual insecticide spraying (IRS) Insecticide-treatedBed Nets (ITN) Prevention Cure DrugTreatment • ACT (artemisinin-combination therapies) • Coartem (artemether – lumefantrine) is on the WHO’s Model List of Essential Medicines

  4. Coartem is the result of unique partnerships with Chinese institutions and WHO Coartem is a combination drug of artemether, an artemisinin derivative from the plant extract of Artemisia annua, and lumefantrine Artemisia annua has been used for centuries in the traditional Chinese medicine 1994: Unique collaboration starts between Novartis (Ciba-Geigy) and Chinese partners for the development of Coartem 1997: Novartis CEO Daniel Vasella remained committed to the project for the benefit of millions of patients despite negative return-on-investment 2001: Novartis committed to make Coartem available without profit to public sector agencies and malaria-endemic countries under an unique private-public agreement with WHO Prof Zhou Yi-qing Dr Daniel Vasella

  5. Coartem deliveries in 2008 reached 74 Mio (106% CAGR vs. 2004 and +12% vs. 2007) 7% 580% 125% Deliveries Excess production capacity Produced, but not picked up in 2005 100 100 100 100 CAGR 2004-2008106% (mio Tx) 74 12% ErraticOrders 66 62 62 33* Supply Challenges Funding Uncertain Global Policy Uncertain 4 1.3 9 0.1 0.2 *14 mio Tx were ordered for delivery in 2005, but only 9 mio were picked up

  6. Putting 74 Million Treatments into Perspective 20 jumbo cargo planes full in 2008 97% cure rate Potential to cure as many patients as the population of France

  7. Deliveries to African Countries in 2008;worldwide 54 countries deploying ACTs of which 45 Coartem Top 10 country deliveries (Mio Tx; total 74 in 2008) Tanzania: 15.9 Uganda: 11.4 Kenya: 6.9 Mozambique: 6.3 Nigeria: 4.7 Malawi: 4.5 Ethiopia: 4.1 Angola: 3.0 Benin: 2.8 Others: 14.1 7

  8. Production of Artemisinin Combination Therapies : longer and more complex than most drugs Minimum 14 months lead time, if capacities are established Artemisia annua plantation and harvesting (7 months) Artemisinin extraction and Chemical modification (3 months) Drug Product manufacture and shipment (4 months) Expanded artemisinin production in China and Africa Dedicated pharmaceuticals production / packaging in Suffern, US Transferred chemical production from Switzerland to China

  9. Employing a strategy of prevention plus treatment yields real patient impact Rwanda: 66% reduction in mortality Ethiopia: 50% reduction in infant mortality Zambia: At Macha Mission Hospital (rural) 90% reduction of pediatric malaria cases South Africa: KwaZulu Natal cases reduced by 78% in 2001 and 86% in 2002 hospital admissions for malaria reduced by 82% Insect Spraying Coartem Reduction of malaria cases in KwaZulu Natal

  10. Novartis patient centric approach Fast and reliable delivery of high quality drugs, not-for-profit Training of Health- care Professionals(several languages, e.g. Swahili) Best Practice Workshops with National Malaria Control Program Managers Patient Booklet and Education through Coartem packaging and patient information

  11. Malaria Initiatives: In Patient Numbers, Largest Corporate Citizenship Program in Company’s Portfolio Novartis Foundation for Sustainable Development Novartis Research Institutes Malaria Initiatives Patient Assistance programmes • Donation of Leprosy medication: more than 4 million patients cured since 2000 • Donations of fixed-dose TB combination Tx: aiming at 0.5 million patients over 5 years • Novartis Institute for Tropical Disease (NITD) in Singapore • Dengue fever, TB, malaria • Leverage global knowledge to fight neglected diseases • Novartis Vaccines Institute for Global Health (NVGH) in Siena, Italy • First priority diarrheal diseases • Since 2001, 216 million Coartem treatments supplied at not-for-profit to public sector • R&D – vulnerable patient populations: • Pediatric formulation • Pregnancy registry • Patients reached in 2008: 70 million • Glivec cancer treatment: provided to over 27,000 patients in over 83 countries free of charge • Discount program for the uninsured In 2008, Novartis contributed estimated USD 1.259 billion worth of medicines through access to medicines programs for patients in need.

  12. Malaria and the UN Millennium Development GoalsCoartem program addresses 5 of 8 Millennium Development Goals Eradicate extreme poverty and hunger Achieve universal primary education Promote gender equality & empower women Reduce child mortality Improve maternal health Combat HIV/AIDS, malaria & other diseases Ensure environmental sustainability Develop a global partnership for development At UN Millennium Summit in September 2000, pledge to make a better world for all by 2015: Specific to malaria: reduce malaria morbidity and mortality by 75% by 2015

  13. Agenda • The Coartem legacy • Rolling out Coartem Dispersible

  14. The Need for Child-Sized MedicineMalaria and Children: The Challenge Saving Young Lives: Pediatric Malaria Facts 1,000,000 # of malaria deaths annually 700,000 # of children under 5 who die each year 30 Every 30 seconds a child dies from malaria 0 # of child-sized ACTs* *Refers to ACTs approved by stringent health authorities and WHO prequalified

  15. The First ACT for ChildrenCoartem Dispersible: The Solution Sweet-tasting, dispersible tablets ease administration, improve compliance Provided without profit to malaria-endemic regions 1st malaria innovation targeting children, resulting from a Public Private Partnership Underscores Novartis’ commitment to reaching MDG goals

  16. Coartem Dispersible: Rolling Out in Africa Coartem Dispersible Phase III data published in The Lancet on 15 October 2008 High Cure Rates of 97.8% Coartem Dispersible tablet already approved in 17 African countries: Benin, Burkina Faso, DRC, Gabon, Ghana, Guinea, Ivory Coast, Kenya, Madagascar, Mauritania, Niger, Nigeria, Senegal, Togo, Uganda Zambia, Mali Swissmedic approval granted December 2008 WHO prequalification granted March 2009

  17. Publication of Phase III study results in The Lancet

  18. Coartem Dispersible pre-Launch Preparation Activities October November December January February Country Roadshows SwissmedicApproval Dec 08 NMCP Workshops November 2007 May 2008 Swiss CPPs African Approvals depending on CPP International Congress of Trop. Med. & Malaria (Korea) NMCP Workshop, Kenya 57th ASTMH (US) Publication in The Lancet 56th ASTMH (US) Congresses Regulatory Milestone Stakeholder Management

  19. Coartem Dispersible Launch Events Coartem Dispersible media briefing Basel, 27 Jan 2009 • Technical Briefing • Geneva, 2 Feb 2009 Malaria panel Davos, 31 Jan 2009 Launch of Coartem Dispersible London, 23 March 2009 • African launch events • for Recipients • Tanzania, 16 Feb 2009 • Mozambique, 19 Feb 2009 • Senegal, 20 Feb 2009

  20. The strategy is adjusted to the various patients groups stratified according to body weight or age • Integral switch • Children 5 < 15 kg and 15 < 25 kg body weight • ~3 months to ~8 years • Children 25 < 35 kg body weight • ~8 to ~12 years • Switch depends on demand (pull strategy)

  21. Price of Coartem Dispersible tablets will match price of Coartem regular tablets • Price of Coartem regular tablets was reduced by more than 50% compared to two years ago • Price reductions occurred in 2 steps: • September 2006 and April 2008

  22. Coartem Dispersible roll-out principles • National regulatory approval • Green light from National Malaria Control Programme • Procurement agent support • Once a country has received Coartem Dispersible tablets, no regular Coartem deliveries will be made anymore

  23. Timelines for switching to Coartem Dispersible will differ from country to country • First orders for Coartem Dispersible received from Mozambique and Zambia • For delivery in April and June • A few other countries have requested that confirmed deliveries of Coartem regular tablets be maintained in H2 and will order Coartem Dispersible tablets in H2 09

  24. Collaboration is KeyNovartis and MMV pioneering the fight against malaria Innovation Funds Drug Supply Working Together For Sustainable Health Impact Healthcare Infrastructure OrderlyDistribution

  25. Saving Precious Lives An Achievable Goal in Malaria

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